Clearance Summary
FASTEC 901 AGGLUTINATION PATTERN READER received FDA 510(k) clearance under submission number K895967, sponsored by Schiff & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1989-10-30.
- Submission: K895967
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1989-10-30
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.